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The possibility that silicone gel-filled breast implants may lead to adverse autoimmune reactions had been a central allegation of the plaintiffs throughout the breast implant litigation. The purely descriptive data of an association between implants and disease introduced by the plaintiffs was of limited value in the absence of data from a comparable group of women without implants. In order to gauge the relative risk of disease in women who have had silicone breast implants as compared to the general population, cohort and case-control epidemiological studies were needed.
Two main types of epidemiological studies were utilized to examine the risk of connective tissue diseases in women with silicone breast implants and the general population: cohort and case control studies. In a cohort study, the incidence and nature of diseases in women with silicone breast implants are obtained by following the group for a specified period of time; this data is then compared to the incidence rate with a randomly identified control group of similarly situated women without breast implants. The first reliable epidemiological study to determine whether breast implants are associated with connective tissue disease was not published until June 16, , two years after the FDA issued its ban on silicone breast implants.
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The study was a retrospective population-based cohort study that compared the risks of a variety of connective tissue diseases and disorders in women with and without breast implants. Of the devices implanted, All case subjects were exposed to silicone because all the breast implants were contained within a silicone envelope.
For each case subject, the control subjects were two women of the same age within three years from the same population who had not received a breast implant and who underwent a medical evaluation within two years of the date of implantation of the case subject. A total of women who received a breast implant were followed for a mean of 7. Among the various signs or symptoms examined, only morning stiffness was significantly increased among the women who had received a breast implant.
The study concluded, therefore, that there was no association between breast implants and the connective tissue diseases and disorders studied. The study followed women without connective-tissue diseases in June through May 31, , before widespread media coverage of the possible association between implants and disease began. The study defined the relative risk of connective tissue disease as the incidence rate of connective tissue disease among women with breast implants divided by the corresponding incidence rate among women without breast implants.
Among 87, women who were eligible for follow-up, the researchers confirmed that of the participants had definite connective-tissue diseases and had breast implants of which were silicone-gel, saline. Three of the patients with definite connective tissue disease all had rheumatoid arthritis had implants one silicone, one saline and one double lumen.
Moreover, since , women reported having a connective-tissue disease or rheumatic disorder on the biennial questionnaires.
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Of these women, thirty-two had some type of breast implant, including twenty-one women with silicone gel-filled implants. Of these women, seventeen had some type of breast implant and eleven had silicone gel-filled implants. Based upon these findings, the study authors concluded that they could not find an association between silicone breast implants and connective-tissue diseases, as defined by a variety of standardized criteria and signs and symptoms of these diseases. As the cases under the MDL became ready for trial, Judge Pointer returned several of them to their districts of origin with the expectation that early trials would set benchmarks to encourage later settlement negotiations.
Among these cases was a group of approximately seventy cases returned to the District of Oregon that gave rise to Hall v. Baxter Healthcare Corp. A selection panel of six experts provided the court with the names of neutral, impartial experts to serve on the National Science Panel NSP who would be able to communicate effectively with judges and juries. Tugwell received financial support from Bristol-Meyers Squibb and 3M Pharma Canada, silicone breast implant manufacturers, for research unrelated to breast implants or the litigation.
Although the allegations were, for the most part, beyond factual dispute, the court concluded that a scientist may act neutrally and objectively, even when the outcome of his research may adversely affect a company that provides funding for his other projects. In October and July , the NSP heard testimony from experts from both sides of the litigation and in November experts selected by the NSP presented their research to the panelists.
In preparing their report, the panel was asked to identify the extent to which, if any, existing studies and research provided a reliable and reasonable scientific basis to conclude that silicone gel-filled breast implants cause or exacerbate classic or atypical connective tissue diseases. Nevertheless, as in every field of endeavor, a few individuals may find disagreements with our statements.
The completed report contained over pages of scientific analysis and review and included nine cohort, nine case control, and two cross-sectional studies in its meta-analysis of the relationship between silicone breast implants and connective tissue diseases.
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The panel found that the same complaint often appeared in more than one disease category and the studies did not verify self-reports of the disease. Moreover, the report concluded that the preponderance of the data did not support claims that silicone implants alter the incidence or severity of autoimmune diseases. The IRG examined case control and cohort studies conducted between and and concluded that, if there is a risk of connective tissue disease in women with silicone breast implants, it is too small to be quantified.
In House Report , which accompanied a appropriations bill, Congress expressed concerns about the fragmentation of research regarding the safety of silicone breast implants and their possible relationship with connective tissue or other autoimmune diseases. The Committee included experts in the fields of preventive and internal medicine, nursing, family and women's health, rheumatology, clinical and basic research, epidemiology, immunology, neurology, silicone chemistry, toxicology, breast and other cancer, plastic surgery, and radiology or mammography.
While preparing its report, the Committee relied on approximately 2,, published, peer-reviewed scientific reports, 1,, selected industry technical reports, books, letters, opinion pieces, written statements, and abstracts as secondary sources, and presentations by scientists, women with implants, and other interested parties.
The Committee concluded that no evidence supports an alleged association between silicone breast implants and connective tissue or other autoimmune diseases. The IOM released its report after the Independent Review Group and the National Science Panel published their comprehensive reviews of the literature regarding the safety of silicone breast implants. Although epidemiological studies have overwhelmingly been unable to demonstrate a link between silicone breast implants and autoimmune diseases, there are still prevalent safety concerns associated with the devices.
Concerns with local complications such as capsular contractures, implant leakage and rupture, and mammography difficulties still require further safety review. For example, in a study published in the New England Journal of Medicine , researchers concluded that local complications that require additional surgical procedures, such as capsular contractures, implant rupture or leakage, hematoma or bleeding, infection, or chronic pain, are an important concern for women with breast implants.
During a mean 7. Similarly, in its report, the IOM found that local complications are still a cause for concern for several reasons. First, complications including reoperations, ruptures, contractures, infections and pain occur frequently enough to be a cause for concern and are the primary safety issues with silicone gel-filled breast implants.